Principal Statistical Programmer (Remote) — SAS + R

Farmatalent; País Vasco; Remote; EUR 90,000 - 130,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely as part of a sponsor-dedicated team.

You will implement reporting and analysis activities for sponsor trials, oversee CRO programmers, and ensure high-quality data deliverables across multiple studies. The role requires 7+ years of experience, expert SAS skills, CDISC proficiency, and ability to work independently with strong leadership and communication.

Qualifications

• Minimum 7+ years as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and demonstrate strong leadership and communication.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables and graphs.
• Deliver high-quality SAS and/or R programs tailored to clinical development needs.
• Oversee CROs' statistical programming deliverables and ensure timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project goals.
• Draft SOPs and work instructions related to statistical programming practices.

Skills

SAS programming

CDISC standards (SDTM/ADaM/Define.xml)

Regulatory submissions experience

Independent work

Leadership

Communication skills

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely as part of a sponsor-dedicated team.

You will implement reporting and analysis activities for sponsor trials, oversee CRO programmers, and ensure high-quality data deliverables across multiple studies. The role requires 7+ years of experience, expert SAS skills, CDISC proficiency, and ability to work independently with strong leadership and communication.